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临床试验/CTRI/2018/03/012713
CTRI/2018/03/012713尚未招募2 期

A Prospective Open Labelled Phase II Non Randomized clinical study of NELLI KUDINEER for RATHAMOOLAM(Bleeding Haemorrhoids)

Dr S Neelavathi Md PhD1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年3月4日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Therapeutic efficacy of trial drug Nelli kudineer in Rathamoolam

研究概览

简要总结

The study is A Prospective Open Labelled Phase II Non Randomized clinical study to evaluate the therapeutic efficacy of NELLI KUDINEER  100ml OD for 30 days  in 40 patients during the trial period of 15 months that will be conducted in Govt Siddha Medical College and hospital Palayamkottai Tirunelveli Tamilnadu The primary outcome will be the therapeutic efficacy of trial drug NELLI KUDINEER in RATHAMOOLAM  The secondary outcome will be the evaluation of Siddha diagnostic parameters Safety of trial drug Pharmacological and Biochemical analysis of trial drug

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patient with haemorrhoids in grade I II III with clinical symptoms such as Bleeding per rectum Irregular bowel habits Constipation Prolapse of pile mass Itching around anus Tenesmus and Anemia.

排除标准

  • Fissure Fistula in ano Prolapse of rectum Sentinel haemorrhoids Malignancy Rectal polyp Pregnant women Chronic Kidney,Liver and cardiac diseases.

结局指标

主要结局

Therapeutic efficacy of trial drug Nelli kudineer in Rathamoolam

时间窗: 30 days

次要结局

  • Evaluation of Siddha diagnostic parameters Safety of trial drug Pharmacological and Biochemical analysis of trial drug(30 days)

研究者

发起方
Dr S Neelavathi Md PhD
申办方类型
Government medical college

研究点 (1)

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